AgaMatrix Jazz Wireless 2 Owner's Manual
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AgaMatrix Jazz Wireless 2 Owner's Manual

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  • Page 2 It can be downloaded from the App Store or on Google Play Small size – The AgaMatrix Jazz Wireless 2 Meter is small and portable, for easy testing on the go. System Requirements (Meter and App) A compatible iOS or Android device.
  • Page 3 In case of emergency, contact your healthcare professional or emergency medical response. By using the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (Meter) with the AgaMatrix Diabetes Manager (the App). You agree that the use of this software together with an iPod, iPhone or iPad (“Apple Product”) shall only be as a personal organization or supplemental...
  • Page 4 For patent information, see www.agamatrix.com/patents The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by AgaMatrix, Inc. is under license. Other trademarks and trade names are those of their respective owners.

  • Page 5: Table Of Contents

    PAGE Important Information About Your AgaMatrix Jazz Wireless 2 System Important Safety Instructions The AgaMatrix Jazz Wireless 2 System Kit About the Meter, Test Strips, and Lancing Device Pairing and Syncing Your Meter with the App Important Information about Performing...

  • Page 6: Title

    CHAPTER TITLE PAGE Important Cleaning and Disinfection Procedures Batteries Error Messages Troubleshooting AgaMatrix Jazz Wireless 2 System Specifications Electrical Safety and Standards Warranty...

  • Page 7: Important Information About Your Agamatrix Jazz Wireless 2 System

    AgaMatrix Jazz Wireless 2 System AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System Intended Use: The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is intended for quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip.
  • Page 8 Owner’s Guide. Ensure that the retail carton has not been damaged. You should sync your meter to the AgaMatrix Diabetes Man- ager App (the App) to set your meter’s time and date before testing.
  • Page 9 The AgaMatrix Jazz Wireless 2 blood glucose monitoring system measures a glucose concentration in a sample of fresh capillary whole blood drawn from the fingertip. WaveSense™ is the technology used in AgaMatrix Meters. After insertion of a test strip into the AgaMatrix Jazz Wireless 2...
  • Page 10 AgaMatrix Control Solutions AgaMatrix Control Solutions Levels 2 and 4 are for use with the AgaMatrix Jazz Wireless 2 Blood Glucose Meter and AgaMatrix Jazz Test Strips to check that the meter and test strips are...
  • Page 11 App. See Chapter 5 for more information. Supported Devices The AgaMatrix Diabetes Manager, “the App”, is an application that allows users to add, modify, and view health data, includ- ing glucose, insulin, carbs, and weight. The App works on a variety of iOS and Android devices.

  • Page 12: Important Safety Instructions

    Important Safety Instructions The meter and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients! All parts of the kit are considered biohazardous and can poten- tially transmit infectious diseases, even after you have performed cleaning and disinfection.

  • Page 13: The Agamatrix Jazz Wireless 2 System Kit

    · “Infection Prevention during Blood Glucose Monitoring and Insulin Administration” (2012) The AgaMatrix Jazz Wireless 2 System Kit The System Kit Contains: • AgaMatrix Jazz Wireless 2 Blood Glucose Meter • Two Pre-installed CR2032, 3 Volt, Lithium Batteries • Lancing Device with Cap • 10 Sterile Lancets •...
  • Page 14 It is on the opposite side of the meter’s strip port. It is used to turn on the meter and view past glucose test results. (3) Test Strip Port: Insert the AgaMatrix Jazz Test Strip, with the contact bars facing up, into the test strip port.
  • Page 15 Important Test Strip Information: • Store the AgaMatrix Jazz Blood Glucose Test Strip vial in a cool, dry place at 46°F to 86°F (8°C to 30°C) and at a rela- tive humidity of 10% to 90%.
  • Page 16 • With clean, dry hands you may gently handle the AgaMatrix Jazz Blood Glucose Test Strip when removing it from the vial or inserting it into the meter. • After removing an AgaMatrix Jazz Blood Glucose Test Strip from the vial, immediately close the vial cap tightly.
  • Page 17 About the AgaMatrix Lancing Device (1) Cocking Handle: Cocks the device so it is ready to lance. (2) Depth Adjustment Dial: Adjusts how deep the lancet will lance the skin. (3) Depth Indicator Window: Displays the depth setting of the lancing device.

  • Page 18: Pairing And Syncing Your Meter With The App

    Pairing and Syncing Your Meter with the App The AgaMatrix Diabetes Manager (“the App”) is an application that allows users to add, modify, and view health data, including glucose, insulin, carbs, and weight. If you want to sync readings from your meter to the App and set your meter’s time and date, you must pair your meter with...
  • Page 19 Pair Versus Sync All devices that communicate via Bluetooth® wireless technology need to first “pair” with each other so they can establish a connection and get authorized to communicate with each other. You will only have to pair your meter to another device one time.
  • Page 20 [2] Navigate to the Menu: Tap on the icon made of three lines. [3] Tap on “Meters” [4] Tap “Add a new meter” [5] On your meter, press and hold the Meter Button. [6] Tap on your meter’s serial number when it appears in the App.
  • Page 21 Note: Test results taken prior to the time and date being set will not have a time and date associated with them on the meter. You can manually add these readings to the App to include them in your statistics. Test results without a set time and date will be displayed on your meter with “--:--“...
  • Page 22 Before pairing with an additional supported device, turn off Bluetooth® on any devices already paired with your meter. This will ensure connection with your additional supported device. Then follow the steps for “Pairing for the First Time” to pair with the new device. How to Un-pair the App from the Meter [1] In the App, tap on the Menu icon, then tap on “Meters.”...
  • Page 23 For example: if your supported device is set to 12 hour time, the meter’s time will be set to 12 hour time. If your device is set to 12 hour time, you will see an “a” or “p” next to the time. Example of 12 hour time: Example of 24 hour time: For example: a date of “10/12”...
  • Page 24 Force Data Transfer (Sync) If you suspect that data is not being transferred from the meter to the App, you can force the two to sync. [1] In the App, navigate to the “Meters” section of the menu. [2] You should see your meter listed. If there are no meters listed, you must pair your meter to your App.

  • Page 25: Important Information About Performing Control Solution Tests

    Important Information about Performing Control Solution Tests The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System should only be used with AgaMatrix Control Solution. There are two Control Solutions available: Level 2 and Level 4. To order either Level 2 or Level 4 Control Solution, please contact Customer Service.

  • Page 26: Control Solution Tests

    Important AgaMatrix Control Solution Information: [1] Use only AgaMatrix Control Solution with your AgaMatrix Jazz Wireless 2 Meter. [2] Always shake the control solution bottle before use. [3] Always discard the first drop of control solution and wipe the bottle tip clean using a clean tissue or paper towel.
  • Page 27 temperature range of 50°F to 104°F (10°C to 40°C) and an operating relative humidity range of 10%-90%. [7] Failure to shake the control solution bottle vigorously before using. [8] Failure to discard the first drop of control solution and to wipe the bottle tip clean.

  • Page 28: How To Perform A Control Solution Test

    How to Perform a Control Solution Test [1] Inserting a Test Strip: Insert a test strip into the meter’s test strip port. Make sure you insert the test strip into the strip port with the contact bars facing towards you. The meter will turn on when the test strip is inserted.
  • Page 29 Apply Sample to Test Strip Animation: [3] Applying Control Solution: 1. Shake the control solution bottle. 2. Discard the first drop of control solution. 3. Wipe the bottle tip clean using a clean tissue or paper towel. 4. Dispense a second drop onto a clean surface, such as an unused resealable plastic bag.
  • Page 30 [4] Remove the Test Strip from Control Solution Sample When the Test Strip’s Visual Fill Window Completely Turns Blue: The entire visual fi ll window will turn blue. The sample applied symbol will appear on the meter’s screen and will beep when the meter recognizes the control solution and has enough to calculate a result.
  • Page 31 The control solution test result is stored in the meter’s memory but will not transfer to the App during syncing. Example Result: Compare the result of your control solution test to the range printed on your test strip vial label for the control solution level that you used.

  • Page 32: Before You Test Your Blood - Important Health-Related Information

    [6] Remove the Used Test Strip From the Strip Port: Control solution test results will not be sent to the App on your supported device. Removing the used test strip will turn off your meter. [7] Dispose of Used Materials Properly: Follow your healthcare professional’s instructions for disposal.
  • Page 33 [4] Results below 70 mg/dL may mean low blood glucose levels (hypoglycemia). [5] Results over 240 mg/dL may mean high blood glucose levels (hyperglycemia). Checking ketones may be advisable. [6] If you get results below 70 mg/dL or above 240 mg/dL and do not have symptoms of hypoglycemia or hypergly- cemia, repeat the test.
  • Page 34 [12] Prior to performing a blood glucose measurement be sure the testing environment is between the operating temperature and relative humidity range of your system (found at the back of this Guide). Expected Values/Reference Range Expected blood glucose levels for people without diabetes: Fasting <100 mg/dL, two hours after meals <140 mg/dL.

  • Page 35: How To Test Your Blood Glucose Level

    How to Test Your Blood Glucose Level IMPORTANT: You must pair your meter to the App to be able to sync readings from your meter to the App and set your meter’s time and date. For instructions on how to pair refer to Chapter 5.
  • Page 36 Replace Lancing Device Cap: Replace the lancing device cap until it snaps into place. Be careful not to touch the exposed needle on the lancet. Set the Lancing Level: The AgaMatrix Lancing Device offers 8 depth settings. Rotate the dial to the desired setting as shown in the depth indicator window.
  • Page 37 test strip port. Make sure you insert the test strip, with the contact bars facing towards you, into the test strip port. The meter will turn on. [3] Meter Ready For Test: The meter now displays the apply sample to test strip animation, indicating it is now ready for you to apply blood.
  • Page 38 blood drop forms. Do not squeeze directly around the lanced area! [6] Bring Test Strip to Blood Sample: Immediately bring the meter with the inserted test strip to the blood sample at a 90 degree angle. The test strip fills from the tip. Do not try to smear blood on the top surface.
  • Page 39 [7] Remove Your Finger From the Test Strip When the Test Strip’s Visual Fill Window Completely Turns Red and the Meter Beeps: During testing, the sample applied symbol will appear on the meter’s screen and the meter will beep when you should remove the test strip from the blood sample.
  • Page 40 PRECAUTIONS: • Remove the test strip from the blood sample as soon as the test strip’s visual fill window completely turns red (you will also hear a beep). • Do not press the test strip against the test site. • Do not scrape blood onto the test strip. •...
  • Page 41 Glucose Display Messages CAUTION: Low or high blood glucose test results can indicate a potentially serious medical condition. Follow your healthcare professional’s recommendations. LOW MESSAGE: Glucose test result is lower than 20 mg/dL. This low result may indicate hypoglycemia (low blood glucose). It also indicates that the result is below our measuring range.
  • Page 42 will be represented as 600 mg/dL in the statistics in the App. ACTIONS: If you feel symptoms such as fatigue, thirst, excessive urination, or blurry vision, follow your healthcare professional’s recommendations. If you get a high glucose test result but have no symptoms of high blood glucose, then retest with a new test strip.
  • Page 43 Place the lancet cover onto a hard, even surface (such as a tabletop) with the open end facing up. While the lancet is still in the lancing device, bring the lancet tip to the lancet cover to recover the used lancet. You can then safely handle the used lancet.

  • Page 44: Viewing Past Test Results On Your Meter

    WARNING: The information from the App should only be used as a reference. Do not make treatment decisions based solely on the information provided by the App. All health-related decisions should be made in conjunction with the advice of a qualified healthcare professional (HCP). It is important that you and your HCP understand how the statistics are calculated before making any adjustments to treatment.

  • Page 45: Important Cleaning And Disinfection Procedures

    If it was a control solution test result, the control solution icon will appear to the right of the test result. Example Result: Test results without a set time and date will be displayed on your meter with “--:--“ and “--/--“ in place of the time and date. These readings will not sync to the app.
  • Page 46 The meter and lancing device should be cleaned with a separate wipe prior to each disinfection. Cleaning and disinfecting your AgaMatrix Jazz Wireless 2 Meter and Lancing Device CAUTION: Never immerse the meter or the body of the lancing device in water or any other liquid solution.
  • Page 47 (260 cleaning wipes plus 260 disinfecting wipes) on the lancing device and meter. The life of the AgaMatrix Jazz Wireless 2 Meter, defined as 5,000 test strip insertions, is between 3 to 5 years, depending on use. The number of cleaning and disinfecting wipes used simulates cleaning and disinfecting your meter once a week for 5 years.
  • Page 48 turn on, or if the lancing device or adapters do not work after cleaning and disinfection, discontinue use of the system and contact Customer Service. Availability of disinfecting wipe may vary. For updated informa- tion, call Customer Service. Table 1 EPA # Brand Name Manufacturer...
  • Page 49 You should wash your hands thoroughly with soap and water after handling the meter, lancet, lancing device, and test strips. If you require technical assistance regarding cleaning and disinfecting your AgaMatrix Jazz Wireless 2 Meter or lancing device, call Customer Service at 1 (866) 906-4197.

  • Page 50: Batteries

    Batteries Your meter comes with two pre-installed CR2032, 3 volt, lithium batteries. CR2032 CR2032 Batteries are harmful if swallowed. Keep away from small children. LOW BATTERY MESSAGE: (This message appears for 2 seconds.) You can still perform a test when you see a low battery message, but you should replace your batteries as soon as possible.
  • Page 51 NOTE: Dispose of used batteries according to your local environ- mental regulations. Your meter is also an electronic device. When disposing of your meter, follow all local environmental regulations. How to Replace the Batteries: [1] Open Battery Door: Make sure the meter is off. Turn the meter so you are looking at the battery door.

  • Page 52: Error Messages

    Make sure that the battery door is completely closed before using the meter. Error Messages The AgaMatrix Jazz Wireless 2 Meter is designed to work accurately under most usual conditions. On rare occasions, the meter will display an error message instead of a glucose result.
  • Page 53 Error 1: Problems have occurred that are related to test strip use. [1] If this message appears the moment the test strip is in- serted, the test strip may be wet or damaged. [2] If the message appears during a test, the test strip may have been removed too early.
  • Page 54 vial for the expiration date. Do not use test strips beyond the expiration date or 180 days after first opening the vial. You may need to retest using a new test strip from a new vial of test strips. [2] The test strip may have been mishandled by vigorous bending or shaking.
  • Page 55 tion of high glucose and other medical conditions. [2] If this error code persists on retesting, call Customer Service or consult your healthcare professional. Error 6: The test strip has taken too long to generate a signal. [1] This may be caused by a combination of cold operating temperature and high haematocrit levels.
  • Page 56 LOW TEMPERATURE MESSAGE: The meter is below its system operating temperature range of 50°F to 104°F (10°C to 40°C). ACTIONS: Move to an area with an ambient temperature range of 50°F to 104°F (10°C to 40°C) and relative humidity range of 10% to 90%.

  • Page 57: Troubleshooting

    Troubleshooting Troubleshooting Situation #1: Meter does not display the Apply Sample to Test Strip Animation after inserting a test strip. [1] CAUSE: The meter’s batteries have insufficient power. ACTION: The meter’s batteries must be changed immediately. Sync the meter with your supported device to set the date and time.
  • Page 58 [1] CAUSE: Defective test strip. ACTION: Repeat the test with a new test strip. If this does not work, call Customer Service. The phone number is printed on the back of your meter. [2] CAUSE: Sample was applied after 90 seconds of inserting a test strip.
  • Page 59 other and attempt to force sync the two devices. [4] CAUSE: The blood glucose test results do not have a time and date, and show “--:--“ and “--/--“ in place of the time and date. ACTION: Blood glucose test results without a time and date will not sync to the App.
  • Page 60 Troubleshooting Situation #4: Meter is paired with more than one supported device but results are not syncing to all supported devices. (For example, your meter is paired with an iPhone® and Android™ phone, but results are only syncing to the iPhone®). CAUSE: Meter only establishes a connection with one supported device at a time.
  • Page 61 Troubleshooting Situation #6: Passkey does not appear on the meter when pairing with a supported device. [1] CAUSE: The meter has previously been paired with the supported device. ACTION: If the meter was paired with a supported device and then unpaired, a passkey may not be required when pairing again with the same supported device.

  • Page 62: Agamatrix Jazz Wireless 2 System Specifications

    CAUSE: Meter has not recently synced with your supported device. ACTION: See Chapter 5 to sync your meter with your supported device. AgaMatrix Jazz Wireless 2 System Specifications TECHNICAL SPECIFICATIONS Assay Method: Dynamic Electrochemistry Maximum Altitude: 10,000 feet...

  • Page 63: Electrical Safety And Standards

    Memory: 300 blood glucose and control solution test results with date, time Power Source: two CR2032 3 volt lithium batteries Automatic Shutoff : 30 seconds after last user action Size: Width 1.18” x Length 2.56” x Height 0.39” (30 mm x 65 mm x 10 mm) Test Strip Storage Temperature: 46°F to 86°F (8°C to 30°C) Test Strip Storage Relative Humidity: 10%-90% Weight: 18.4 g...
  • Page 64 (2) this device must accept any interference received, including interference that may cause undesired operation. FCC guidelines help ensure that the AgaMatrix Jazz Wireless 2 Meter will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not af- fect the use of your meter.
  • Page 65 This meter has been tested for immunity to radio frequency interference over the frequency range 80MHz to 2.5GHz at 3V/m as specified in IEC 61000-4-3. Electromagnetic emissions requirements as per EN 61326-2-6 and IEC 60601-1-2. Its electromagnetic emission is therefore low.

  • Page 66: Warranty

    Warranty Warranty Terms We offer customers who buy (“You”) a new blood glucose meter (defined as “Meter”) within the United States the fol- lowing purchase protections. We extend a limited lifetime warranty to customers who buy a new Meter. Under this limited warranty, Your new Meter is covered for the period of ownership as long as it has not been modified, altered, or mis- used.
  • Page 68 8100-10155 Rev B...

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